Drug Facts

Drug Facts
SPL v11
SPL
SPL Set ID 5f2b191e-04a4-4c5a-940e-757cb544c189
Route
ORAL
Published
Effective Date 2015-09-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Onion (10 [hp_X]) Ambrosia Artemisiifolia Arsenic Cation (3+) Arundo Pliniana Root Arisaema Triphyllum Root Euphrasia Stricta Naphthalene Chloride Ion Schoenocaulon Officinale Seed Wyethia Helenioides Root
Inactive Ingredients
Potassium Sorbate Water Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2010-01-07

Description

Allium cepa HPUS Ambrosia artemisiaefolia HPUS Arsenicum album HPUS Arundo mauritanica HPUS Arum triphyllum HPUS Euphrasia officinalis HPUS Naphthalinum HPUS Natrum muriaticum HPUS Sabadilla HPUS Wyethia helenioides HPUS Each active ingredient contains equal volumes of 10X, 30X, and LM1 potencies. The letters “HPUS” indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. Product indications are based on Homeopathic Materia Medica.

Purpose

Allium cepa HPUS……………………………………………….Watery eyes Ambrosia artemisiaefolia HPUS……………………………… Sneezing Arsenicum album HPUS……………………………………….Wheezing Arundo mauritanica HPUS……………………………………Cough Arum triphyllum HPUS………………………………………...Hoarseness Euphrasia officinalis HPUS..…………………………………Eye pressure Naphthalinum HPUS…………………………………………..Hay Fever Natrum muriaticum HPUS…………………………………….Difficult breathing Sabadilla HPUS…………………………………………………Nasal discharge Wyethia helenioides HPUS……………………………………Headache


Medication Information

Purpose

Allium cepa HPUS……………………………………………….Watery eyes

Ambrosia artemisiaefolia HPUS……………………………… Sneezing

Arsenicum album HPUS……………………………………….Wheezing

Arundo mauritanica HPUS……………………………………Cough

Arum triphyllum HPUS………………………………………...Hoarseness

Euphrasia officinalis HPUS..…………………………………Eye pressure

Naphthalinum HPUS…………………………………………..Hay Fever

Natrum muriaticum HPUS…………………………………….Difficult breathing

Sabadilla HPUS…………………………………………………Nasal discharge

Wyethia helenioides HPUS……………………………………Headache

Description
  • 30-day supply
  • dropper included
  • Claritose is made without alcohol or sugar. No gluten added.


Mftd for: HelloLife, Inc.

4460 44th St. SE, Ste. C-600

Grand Rapids, MI 49512

FDA Pharmaceutical Establishment

#1053442, #3009727070

www.claritose.com
Uses

for the temporary relief of symptoms commonly associated with allergies, such as:

•    watery eyes

•    coughing

•    sneezing

•    congestion

Indications based on Homeopathic Materia Medic for self-limiting conditions.

Section 50565-1



Keep out of the reach of children.

Section 50566-9

Stop use and ask a doctor if symptoms persist or worsen.

Section 50567-7

When using this product, use only as directed.

Section 50569-3

Ask a doctor before use if

  • you are taking any other medications
  • you have a medical condition
Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Warnings



Directions

Dispense Claritose directly into mouth, or add recommended dosage into 8-12 oz. of purified (non-chlorinated) water and drink. Safe for ages 2 and up.



Dosage By Weight

30-50 lbs                   1/2 mL

(13.6-22.6 kg)             twice per day



50+ lbs                      1 mL

(22.6+ kg)                  twice per day



Other Information



•    do not use if tamper seal is broken

•    store in a cool, dry place

•    product must not come in contact with metal

•    do not store next to electrical devices or appliances



Inactive Ingredients

citric acid, potassium sorbate, purified ionized mineral water.

Questions Or Comments?

You can email us at [email protected] or call us toll-free at

1.800.875.0850. Monday through Friday, 9am-5pm ET

Principal Display Panel

NDC 49726-006-02

CLARITOSE ®

Allergy Symptom Relief

For the temporary relief of symptoms commonly associated with allergies, such as:

  • watery eyes
  • coughing
  • sneezing
  • congestion

2 fl oz (59 mL)

Homeopathic (OTC) Medicine

Active Ingredients (per Dose)

Allium cepa HPUS

Ambrosia artemisiaefolia HPUS

Arsenicum album HPUS

Arundo mauritanica HPUS

Arum triphyllum HPUS

Euphrasia officinalis HPUS

Naphthalinum HPUS

Natrum muriaticum HPUS

Sabadilla HPUS

Wyethia helenioides HPUS





Each active ingredient contains equal volumes of 10X, 30X, and LM1 potencies. The letters “HPUS” indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. Product indications are based on Homeopathic Materia Medica.


Structured Label Content

Uses

for the temporary relief of symptoms commonly associated with allergies, such as:

•    watery eyes

•    coughing

•    sneezing

•    congestion

Indications based on Homeopathic Materia Medic for self-limiting conditions.

Description (34089-3)
  • 30-day supply
  • dropper included
  • Claritose is made without alcohol or sugar. No gluten added.


Mftd for: HelloLife, Inc.

4460 44th St. SE, Ste. C-600

Grand Rapids, MI 49512

FDA Pharmaceutical Establishment

#1053442, #3009727070

www.claritose.com
Section 50565-1 (50565-1)



Keep out of the reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if symptoms persist or worsen.

Section 50567-7 (50567-7)

When using this product, use only as directed.

Section 50569-3 (50569-3)

Ask a doctor before use if

  • you are taking any other medications
  • you have a medical condition
Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Allium cepa HPUS……………………………………………….Watery eyes

Ambrosia artemisiaefolia HPUS……………………………… Sneezing

Arsenicum album HPUS……………………………………….Wheezing

Arundo mauritanica HPUS……………………………………Cough

Arum triphyllum HPUS………………………………………...Hoarseness

Euphrasia officinalis HPUS..…………………………………Eye pressure

Naphthalinum HPUS…………………………………………..Hay Fever

Natrum muriaticum HPUS…………………………………….Difficult breathing

Sabadilla HPUS…………………………………………………Nasal discharge

Wyethia helenioides HPUS……………………………………Headache

Warnings



Directions

Dispense Claritose directly into mouth, or add recommended dosage into 8-12 oz. of purified (non-chlorinated) water and drink. Safe for ages 2 and up.



Dosage By Weight (DOSAGE BY WEIGHT)

30-50 lbs                   1/2 mL

(13.6-22.6 kg)             twice per day



50+ lbs                      1 mL

(22.6+ kg)                  twice per day



Other Information (Other information)



•    do not use if tamper seal is broken

•    store in a cool, dry place

•    product must not come in contact with metal

•    do not store next to electrical devices or appliances



Inactive Ingredients (Inactive ingredients)

citric acid, potassium sorbate, purified ionized mineral water.

Questions Or Comments? (Questions or comments?)

You can email us at [email protected] or call us toll-free at

1.800.875.0850. Monday through Friday, 9am-5pm ET

Principal Display Panel

NDC 49726-006-02

CLARITOSE ®

Allergy Symptom Relief

For the temporary relief of symptoms commonly associated with allergies, such as:

  • watery eyes
  • coughing
  • sneezing
  • congestion

2 fl oz (59 mL)

Homeopathic (OTC) Medicine

Active Ingredients (per Dose) (Active Ingredients (per dose))

Allium cepa HPUS

Ambrosia artemisiaefolia HPUS

Arsenicum album HPUS

Arundo mauritanica HPUS

Arum triphyllum HPUS

Euphrasia officinalis HPUS

Naphthalinum HPUS

Natrum muriaticum HPUS

Sabadilla HPUS

Wyethia helenioides HPUS





Each active ingredient contains equal volumes of 10X, 30X, and LM1 potencies. The letters “HPUS” indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. Product indications are based on Homeopathic Materia Medica.


Advanced Ingredient Data


Raw Label Data

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